To compare Progression Free Survival (PFS) of nilotinib and imatinib when used as initial therapy in patents with unresectable and/ or metastatic GIST. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare disease control rate (DCR) of nilotinib and imatinib [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

To compare time to treatment failure (TTF) of nilotinib and imatinib [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

To compare overall survival (OS) of nilotinib and imatinib [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

To compare time to progression (TTP), response rate (RR), time to tumor response and assess duration of response of nilotinib and imatinib [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

To compare safety and tolerability of nilotinib and imatinib [ Time Frame: at month 1 and then every 3 months ] [ Designated as safety issue: Yes ]

Histologically confirmed diagnosis of GIST which is unresectable and/or metastatic and either:

have not received any prior anti-neoplastic therapy other than adjuvant imatinib. Note: newly diagnosed patients may have received up to 14 days of treatment with imatinib for disease management while awaiting entry to the study or

recurrent GIST after stopping adjuvant treatment with imatinib and no subsequent treatment with any other therapies.

At least one measurable site of disease on CT/MRI scan

Performance status ≤ 2 (capable of self-care but unable to carry out any work)

Normal organ, electrolyte and marrow function

Exclusion Criteria:

Any prior anti-neoplastic therapy with the exception of patients who have received adjuvant imatinib or patients with newly diagnosed metastatic/ unresectable GIST whose disease requires therapy while awaiting entry to the study.

Disease progression during adjuvant therapy with imatinib

History of active malignancy (other than GIST) within 10 years prior to study entry with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ.

Impaired cardiac function

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785785